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Potential Role of Water-soluble Ubiquinol in Complementary Therapy for Pediatric Dilated Cardiomyopathy

Primary Purpose

Pediatric Dilated Cardiomyopathy

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Water-soluble Ubiquinol
Sponsored by
Chung Shan Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Pediatric Dilated Cardiomyopathy focused on measuring water-soluble ubiquinol supplementation, pediatric cardiomyopathy, antioxidant, inflammation, complementary therapy

Eligibility Criteria

1 Month - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pediatric dilated cardiomyopathy defined as left ventricular ejection fraction ≤ 40 % by cardiac echo examination.

Exclusion Criteria:

  • Hypertension
  • Arrhythmia
  • Congenital heart defects
  • Acute myocarditis
  • Pregnant and lactating teens
  • Antioxidant vitamins users

Sites / Locations

  • Chung Shan Medical University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open label

Arm Description

water-soluble ubiquinol

Outcomes

Primary Outcome Measures

Left ventricular ejection fraction
Left ventricular ejection fraction (%) will be measured by cardiac echo.

Secondary Outcome Measures

Levels of plasma coenzyme Q10
Plasma coenzyme Q10 (micromol/L) will be measured by high performance liquid chromatography.
B-type natriuretic peptide (BNP)
BNP (pg/mL) will be measured by fluorescence immunoassay.
malondialdehyde (MDA)
MDA (micromol/L) will be measured by thiobarbituric acid reacting substance.
catalase (CAT)
red blood cells level of CAT in unit/mg protein.
glutathione peroxide (GPx)
red blood cells level of GPx in unit/mg protein.
superoxide dismutase (SOD)
red blood cells level of SOD in unit/mg protein.
high sensitivity C-reactive protein (hs-CRP)
hs-CRP (mg/dL) will be measured by Immunoturbidimetry.
high sensitivity interleukin-6 (IL-6)
IL-6 (pg/dL) will be measured by immunosorbent assay.

Full Information

First Posted
July 12, 2016
Last Updated
July 10, 2018
Sponsor
Chung Shan Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02847585
Brief Title
Potential Role of Water-soluble Ubiquinol in Complementary Therapy for Pediatric Dilated Cardiomyopathy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
May 30, 2018 (Actual)
Study Completion Date
July 6, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chung Shan Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Pediatric dilated cardiomyopathy (PDCM) is the most common form fond in children. Water-soluble coenzyme Q10 (ubiquinol) is better absorbed than lipid-soluble coenzyme Q10 (ubiquinone) and is directly involved in the antioxidant cycle. Because coenzyme Q10 has shown significant health benefits in adult patients with cardiovascular disease, it is worth studying water-soluble coenzyme Q10 supplements to evaluate their potential role as complementary therapy for PDCM. The purpose of this study is to explore the potential role of water-soluble ubiquinol in complementary therapy for pediatric cardiomyopathy. We will recruit 25 children with primary PDCM (age 0-20 y) and examine the relationship between coenzyme Q10 level and cardiac function (left ventricular fractional shortening and ejection fraction, and B-type natriuretic peptide), oxidative stress (malondialdehyde), antioxidant enzymes activity (catalase, glutathione peroxide, and superoxide dismutase), and inflammation (high sensitivity C-reactive protein and interleukin-6) in PMC after 6 months water-soluble ubiquinol supplementation (10 mg/kg BW/d, by oral drops). In addition, we will assess the quality of life of PDCM patients by questionnaire. Through this study, we expect to demonstrate that water-soluble coenzyme Q10 will be a complementary therapy for PDCM, and will improve cardiac function, increase antioxidant capacity, slow deterioration of cardiac function and reduce inflammation, and further reduce the rate of heart transplantation and increase quality of life in PDCM.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Dilated Cardiomyopathy
Keywords
water-soluble ubiquinol supplementation, pediatric cardiomyopathy, antioxidant, inflammation, complementary therapy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open label
Arm Type
Experimental
Arm Description
water-soluble ubiquinol
Intervention Type
Dietary Supplement
Intervention Name(s)
Water-soluble Ubiquinol
Intervention Description
10 mg/kg BW/d, by oral drops
Primary Outcome Measure Information:
Title
Left ventricular ejection fraction
Description
Left ventricular ejection fraction (%) will be measured by cardiac echo.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Levels of plasma coenzyme Q10
Description
Plasma coenzyme Q10 (micromol/L) will be measured by high performance liquid chromatography.
Time Frame
6 months
Title
B-type natriuretic peptide (BNP)
Description
BNP (pg/mL) will be measured by fluorescence immunoassay.
Time Frame
6 months
Title
malondialdehyde (MDA)
Description
MDA (micromol/L) will be measured by thiobarbituric acid reacting substance.
Time Frame
6 months
Title
catalase (CAT)
Description
red blood cells level of CAT in unit/mg protein.
Time Frame
6 months
Title
glutathione peroxide (GPx)
Description
red blood cells level of GPx in unit/mg protein.
Time Frame
6 months
Title
superoxide dismutase (SOD)
Description
red blood cells level of SOD in unit/mg protein.
Time Frame
6 months
Title
high sensitivity C-reactive protein (hs-CRP)
Description
hs-CRP (mg/dL) will be measured by Immunoturbidimetry.
Time Frame
6 months
Title
high sensitivity interleukin-6 (IL-6)
Description
IL-6 (pg/dL) will be measured by immunosorbent assay.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pediatric dilated cardiomyopathy defined as left ventricular ejection fraction ≤ 40 % by cardiac echo examination. Exclusion Criteria: Hypertension Arrhythmia Congenital heart defects Acute myocarditis Pregnant and lactating teens Antioxidant vitamins users
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping-Ting Lin, Ph.D.
Organizational Affiliation
School of Nutrition, Chung Shan Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chung Shan Medical University
City
Taichung
ZIP/Postal Code
40201
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Potential Role of Water-soluble Ubiquinol in Complementary Therapy for Pediatric Dilated Cardiomyopathy

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